A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec BVBA
• Collaborator: Tibotec Pharmaceutical Limited
• Treatments: Interferon alpha-2; Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL

• Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)

• Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

• Patient is a previous non-responder that is classified as a viral breakthrough case

• Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype

• Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype

• Evidence of decompensated liver disease

• Patient has condition that requires use of systemic corticosteroids